ocrelizumab (Ocrevus)

Brand Names: Ocrevus

Generic Name: ocrelizumab

• What is ocrelizumab (Ocrevus)?
• What are the possible side effects of ocrelizumab (Ocrevus)?
• What is the most important information I should know about ocrelizumab (Ocrevus)?
• What should I discuss with my healthcare provider before receiving ocrelizumab (Ocrevus)?
• How is ocrelizumab given (Ocrevus)?
• What happens if I miss a dose (Ocrevus)?
• What happens if I overdose (Ocrevus)?
• What should I avoid while receiving ocrelizumab (Ocrevus)?
• What other drugs will affect ocrelizumab (Ocrevus)?
• Where can I get more information (Ocrevus)?

Ocrelizumab is used to treat primary progressive multiple sclerosis and relapsing forms of multiple sclerosis in adults (including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease).

Ocrelizumab may also be used for purposes not listed in this medication guide.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver right away if you feel dizzy, tired, nauseated, light-headed, feverish, sweaty, itchy, or have a red skin rash, headache, fast heartbeats, chest tightness, trouble breathing, or swelling and irritation in your throat.

Call your doctor at once if you have:

• fast heart beats, tiredness;
• headache, nausea, dizziness;
• itchy skin, rash, hives;
• fever, chills, cough;
• throat pain or irritation;
• wheezing, breathing problem, feeling short of breath;
• flushing (sudden warmth, redness, or tingly feeling);
• skin sores, blisters, pus, or oozing;
• cold sores or fever blisters on or around your lips;
• nerve pain (tingling, burning pain, "pins and needles" feeling);
• mood or behavior changes, confusion, memory problems;
• weakness on one side of your body; or
• problems with speech, vision, or muscle movement.

Your ocrelizumab treatments may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• skin infections;
• reactions to an injection; or
• cold symptoms such as stuffy nose, sneezing, sore throat.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Some side effects may occur during the injection or up to 24 hours later. Tell your caregiver if you feel dizzy, nauseated, itchy, or have chest tightness, trouble breathing, or swelling in your throat.

Ocrelizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Call your doctor if you have a fever, chills, cough, mouth sores, skin sores or blisters, itching, tingling, burning pain, or problems with speech, thought, vision, or muscle movement.

If you've ever had hepatitis B, it may become active or get worse while you are using or after you stop using ocrelizumab. You may need frequent liver function tests for several months.

You should not be treated with ocrelizumab if you are allergic to it, or if you have:

• active infection with hepatitis B.

Your doctor may perform tests to make sure you do not have hepatitis B or other infections.

You should not receive any "live" or "live-attenuated" vaccine within the 4 weeks before you start treatment with ocrelizumab. If you need a "non-live" vaccine, you should receive it at least 2 weeks before you start treatment with ocrelizumab.

Also tell your doctor if:

• you have any type of active infection;
• you are a carrier of hepatitis B; or
• you have ever used medicine that can weaken your immune system.

Using ocrelizumab may increase your risk of developing certain types of cancer, such as breast cancer. Ask your doctor about your specific risk.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 6 months after your last dose.

If you are pregnant, you will need to tell your baby's doctor if you used ocrelizumab during pregnancy, especially before the baby receives any childhood vaccines.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk.

Ocrelizumab is not approved for use by anyone younger than 18 years old.

Ocrelizumab is given as an infusion into a vein. A healthcare provider will give you this injection.

Your first dose of ocrelizumab will be split into 2 separate infusions given 2 weeks apart. The following doses will be given once every 6 months.

This medicine must be given slowly, and the infusion can take from 2.5 to 3.5 hours to complete.

You may be given other medications to help prevent serious side effects of ocrelizumab.

You will be watched closely for at least 1 hour after receiving ocrelizumab, to make sure you do not have an allergic reaction to the medication.

Ocrelizumab affects your immune system. You may get infections more easily, even serious or fatal infections. Your doctor will need to examine you on a regular basis.

If you've ever had hepatitis B, this virus may become active or get worse during treatment with ocrelizumab or in the months after you stop using this medicine. You may need frequent liver function tests while using this medicine and for several months after your last dose.

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Call your doctor for instructions if you miss an appointment for your ocrelizumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not receive a "live" vaccine while using ocrelizumab or within 4 weeks before you start using this medicine. You could develop a serious infection. Live vaccines include measles, mumps, rubella (MMR), polio, rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Ask your doctor before getting a yearly flu shot while you are being treated with ocrelizumab.

Tell your doctor about all other medicines you have recently used to treat multiple sclerosis.

Other drugs may affect ocrelizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your pharmacist can provide more information about ocrelizumab.

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